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HHS/FDA RIN: 0910-AG73 Publication ID: Fall 2013 
Title: Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements 
Abstract: This final rule will adopt FDA's interim final rule that amended the regulation on record availability requirements, including expansion of FDA records access. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1.361   
Legal Authority: PL 107-188    PL 111-353    5 USC 553(b)(3)(B) and 21 CFR 10.40(e)(1)    5 USC 553(d)(3) and 21 CFR 10.40(d)    21 USC 350c(a)    21 USC 374(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule Comment Period End  05/23/2013 
Interim Final Rule  02/23/2012  77 FR 10658   
Interim Final Rule Effective  03/01/2012 
Final Action  01/00/2014 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
William A. Correll, Jr.
Supervisory Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Room 3C-019, CPK1, HFS-607, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:240 402-1611
Fax:301 436-2716
Email: william.correll@fda.hhs.gov